BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREFUSION

    MDR report key: 5004065 · Received August 12, 2015

    Report

    Report Number
    2021710-2015-01407
    Event Type
    Injury
    Date Received
    August 12, 2015
    Date of Event
    July 16, 2015
    Report Date
    July 16, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K103211
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: 510K NUMBER. (B)(4) SHOULD NOT HAVE BEEN SELECTED ON THE INITIAL MDR. RESULTS OF INVESTIGATION: THE CAREFUSION FAILURE ANALYSIS LAB RECEIVED THE SUSPECTED DEVICE/COMPONENT AND PERFORMED A FAILURE INVESTIGATION. THE REPORTED ISSUE WAS DUPLICATED IN THE LABORATORY SETTING. THE ROOT CAUSE OF THE REPORTED ISSUE WAS A DEAD BACKLIGHT INVERTER BOARD AND A DEAD BATTERY.

    Additional Manufacturer Narrative · 1

    CAREFUSION HAS REQUESTED ADDITIONAL INFORMATION FROM THE DISTRIBUTOR IN (B)(4) ON THE REPORTED EVENT AND STATUS OF THE PATIENT. AS OF AUGUST 12, 2015 THERE HAS BEEN NO ADDITIONAL INFORMATION PROVIDED BY THE DISTRIBUTOR IN (B)(4) PERTAINING TO THAT REQUEST. (B)(4). THE DISTRIBUTOR IN (B)(4) DETERMINED THAT THE MOST LIKELY CAUSE OF THE REPORTED EVENT WAS A FAULTY USER INTERFACE MODULE (UIM). THE DISTRIBUTOR IN (B)(4) WAS SHIPPED A REPLACEMENT USER INTERFACE MODULE (UIM) TO REPAIR THE DEVICE AND RETURN IT TO SERVICE. CAREFUSION ISSUED A RETURN GOODS AUTHORIZATION (RGA) NUMBER TO THE DISTRIBUTOR IN (B)(4) FOR THE RETURN OF THE ALLEGED FAULTY USER INTERFACE MODULE (UIM) FOR EVALUATION. AS OF THE AUGUST 12, 2015, THE ALLEGED FAULTY USER INTERFACE MODULE (UIM) HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    THE DISTRIBUTOR IN (B)(6) REPORTED THAT DURING USE ON A PATIENT THE DEVICE'S SCREEN STATED TO FLICKER AND THE SCREEN EVENTUALLY WENT BLANK AND THE DEVICE CONTINUED TO CYCLE. THE PATIENT WAS REMOVED FROM THE DEVICE AND PLACED ON ANOTHER DEVICE WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527894 CAREFUSION VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION AVEA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention